Mesoblast

In Mesoblast's annual report from August 2010, the company first announced positive results of preclinical trials showing radiographic and pathologic disc regeneration with MPC-06-ID. Mesoblast said they were in the process of completing an Investigational New Drug (IND) submission to the United States FDA to commence Phase 2 clinical trials.[2] In December 2010, Mesoblast entered into an agreement with US-based Cephalon to develop and commercialize novel adult Mesenchymal Precursor Stem Cell (MPC) therapeutics for degenerative conditions of the cardiovascular and central nervous systems.[3]

In September 2011, Mesoblast entered into an agreement with Swiss-based Lonza Group. Under the agreement, Lonza will manufacture the stem cells for Mesoblast's MPC cell products. Mesoblast will also have exclusive access to Lonza's Cell Therapy facilities in Singapore for the manufacture of allogeneic cell therapy.[4]

Osiris sold its MSC drug and patents to Mesoblast Ltd. in 2012.[5] In March 2014, Circulation Journal published the results of a clinical trial using MPCs as adjunctive therapy for patients with a Ventricular Assist Device.[6] In May 2014, Mesoblast announced it would receive incentives from the Singapore Economic Development Board (EDB) for activities in Singapore related to manufacturing operations, as well as product development and commercialization.[7]

On February 10, 2015, Mesoblast was granted a patent by the United States Patent and Trademark Office (USPTO) covering its proprietary Mesenchymal Precursor Cell (MPC) technology for use in the treatment of degenerated intervertebral discs.[8] On March 19, 2015, Mesoblast announced that it has been selected by the Japan External Trade Organization (JETRO) as the only regenerative medicine company worldwide to receive fast-track access to potential investment incentives across all levels of government in Japan[9] In June 2015, Mesoblast received $5.8 million from the Australian Government for Research and Development (R&D) activities conducted during the 2014 financial year. The funds were provided to Mesoblast under the Government's R&D Tax Incentive Program.[10]

In February 2016, Mesoblast's Licensee (JCR Pharmaceuticals Co., Ltd.) sold its first allogeneic cell product for the treatment of acute graft versus host disease (aGVHD) in children and adults in Japan. TEMCELL is the first allogeneic cell therapy to be fully approved in Japan.[11] In December 2016, Mesoblast and Mallinckrodt Pharmaceuticals entered into an agreement to exclusively negotiate a commercial and development partnership for MPC-06-ID in the treatment of chronic low back pain due to disc degeneration.[12]

Mesoblast's solution for back pain came under heavy criticism from competitor Regenexx in August 2015. Dr. Chris Centeno said the trial results were "spit shined" with confusing and misleading language, press releases for phases 1 and 2 did not include images of MRIs to prove that discs were regenerated and expressed doubts about maintaining cell quality while mass-producing cells. He also said the host's immune system removes the injected stem cells.[20]

Mesoblast is listed as MSB on the Australian Securities Exchange (ASX), as MESO on the NASDAQ, and as MEOBF on the ATC Markets.

The company reported its financial results in November 2020.[21] As of September 30, 2020:

• Cash on hand was $108.1 million
• Net loss before tax $25.3 million
• Cash outflows for Q1 FY21 were $24.5 million.